PQS
 Ensure quality and efficacy of medicinal product and safety of patient
 Improve overall quality of phramaceutical company
 must incorporate GMP and PQR (quality risk management) TO ACHIEV EFFECTIVELY
 Covers all product lifecycle (all manufacturing firm) whole

 PRODUCT DISCONTINUATION -
 Technology transfer
  Focuses on different sets of principles and procedures
 Can facilitate better and informed decisions
 More informed and better decisions
QRM
 They can analyse the rsik
 QRM - kahit may potential risk, kaya I-monitor
  

 Potential risks
 Avoid unintended excipients
 Different dosages
 Must have protocol on how to manage the risks

QA-focuses on process-prevent defects

GMP - set of principles and procedures
QC - focuses on the product -
-detect defects- verify the quality of product
 
  All plant and necessary actions will satisfy the
 Quality audits
 Quality assurance
 Prevent defects
 Pro-active process - aims quality products
GMP - part of quality assurance
 As long as we follow procedures
 Set of principles and procedures
QC - testing and prelease procedures

In-process qc -> ipqc tests

Qc- reactive process

 Countries only accept gmp certified companies to ensure quality safety and effectiveness
 Gmp certification required to all company to get LTO certification
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 (((kumakatok pochi, binuksan ko pinto ))))

 Personnel - job description and qualifications of positions

 Protect against contamination - sanitation
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- Documentation - under pharma companies follow alcoa principles

- Attributable - traceable to person who made data-related products (signature/initials, then
date)
o If it's not documented, it did not happen
- Legible - readable & understandable
o Permanent blue ink pen
- Contemporaneous - on-time (time card?)
- Original - all data present (strike thru affix sign or initials then write correction beside, do not
remove/erase)
- Accurate - all are correct
- + complete, consistent, … ,available

- Goal - Produce safe and effective quality products

- Get representative sample for the whole batch
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sPersonnel quali - resume and all

- Positive or negative air flow

- Open or closed sewage
- SOP of cleaning

 Raw materials to finish product ^

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 Production procedures

 
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